Primary responsibility is as the QA lead on R&D combination new product development teams. Mentor/lead product team members through the design control process. Provide product QA support for design control and risk management. Utilize quality engineering methods.

Provide QA support for new drug-device Combination Product development from late stage feasibility through transfer into commercial and/or clinical manufacturing operations

Perform and review/approve design control and risk management activities. Work closely with research and development organization to ensure potential product issues are identified and addressed in the design.

Makes critical, creative and strategic decisions as a result of rapid analysis of available information including risk-assessment for the patient and for the business

Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs by making sound quality judgment from complied factual data provided by the different functional areas, each presenting varied viewpoint of regulatory requirements or project needs and requirements

Level of position is commensurate upon education and experience of the candidate.